During a surgical procedure, there is a need to provide an effective barrier to protect a surgery patient and operating room personnel from transfer of microorganisms, body fluids and particulates that might otherwise cause infections. For example, infectious microorganisms may include Methicillin-Resistant Staphylococcus Aureus (MRSA), which is a bacterium that can lead to skin infections causing redness, swelling, tenderness of the skin and also possibly causing boils, blisters, pustules, and abscesses on the skin. In addition, a body fluid, such as blood, might contain blood-borne pathogens, such as Human Immunodeficiency Virus (HIV) that can lead to impairment of the human immune system. Moreover, Hepatitis B and C viruses are also blood-borne pathogens. The Hepatitis B and C viruses can damage the liver. Particulates, on the other hand, may be dried residue from disinfectants or chemicals. The particulates can migrate into the surgical wound and cause infection or the particulate matter can even, at least partially, clog a catheter tube during the surgical procedure.
Prior to surgery, a surgeon dons the surgical gown to provide the previously mentioned safe and effective barrier to protect the patient and the surgeon from transfer of microorganisms, body fluids and particulates that might otherwise cause infections. However, a conventional surgical gown design typically requires two people to assist the surgeon in donning the surgical gown. The two people are a sterile surgical or “scrub nurse” and a non-sterile “circulating nurse.” The sterile scrub nurse assists the surgeon during the surgical procedure and is allowed within a defined sterile surgical field during the operation. The surgical field is an isolated area in the operating room where surgery is performed and that must be kept sterile at all times using known aseptic techniques. The circulating nurse is an individual who has not scrubbed-in with other members of the surgical team. However, the circulating nurse coordinates, plans and implements other nurse-related duties associated with the surgery. The non-sterile circulating nurse remains at all times outside the sterile surgical field prior to and during the surgical procedure. As mentioned, a conventional surgical gown requires both the scrub nurse and the circulating nurse to assist the surgeon in donning the surgical gown. In this regard, about 11 procedural steps are required in order for the surgeon to don the conventional surgical gown with the assistance of the scrub nurse and the circulating nurse.
The typical two-assistant procedure for donning the conventional surgical gown begins by the scrub nurse assisting the surgeon in placing the surgeon's arms inside the gown's sleeves. The scrub nurse then begins the process of assisting the surgeon in draping the gown over the surgeon's shoulders and front torso. Neither the surgeon nor the scrub nurse touches the outside of the gown, so that sterility of the outside of the gown is maintained. The scrub nurse also assists the surgeon in gloving. That is, the scrub nurse assists the surgeon in pulling sterile surgical gloves over the surgeon's hands according to a predetermined gloving procedure.
As the gown is being draped over the surgeon's shoulders and front torso, the non-sterile circulating nurse, who is standing outside the sterile surgical field and behind the surgeon, assists in the gown donning process by pulling the gown toward and around the back of the surgeon. The circulating nurse then ties and knots a plurality of relatively small strings distributed along two longitudinally opposing edges of the open back portion of the gown. However, there may remain an exposed longitudinal gap separating the two longitudinally opposing edges of the open back portion of the gown. This longitudinal gap may exist even after the circulating nurse has tied and knotted the strings distributed along the two longitudinally opposing edges of the open back portion of the gown. The circulating nurse may also secure the collar of the gown about the neck of the surgeon by closing fasteners (e.g., strings, VELCRO® brand fasteners, or other fasteners) located at the rear neck portion of the gown. VELCRO® is a registered trademark of Velcro Industries, B.V. located in Amsterdam, The Netherlands. As previously mentioned, the circulating nurse never touches the outside of the gown in order to maintain sterility of the gown. Therefore, the circulating nurse will not touch the outside of the collar as the circulating nurse secures the collar of the gown about the neck of the surgeon.
A disadvantage associated with this procedure is that a conventional gown often inadvertently opens-up along the gap at the back of the gown either due to movement of the surgeon or due to inappropriately sized gowns having to fit larger surgeons. Presence of the gap is undesirable because the gap may expose the inside of the gown to the surgical field. As previously mentioned, the inside of the gown is considered non-sterile. Therefore, the surgeon will necessarily limit his movements during the surgical procedure, such that the open gap never faces the patient during the surgical procedure. This limitation on movement necessarily restricts mobility of the surgeon during the surgical procedure. In addition, the non-sterile gap portion of the surgeon's gown may contact the sterile front portion of a gown being worn by an assistant who may be standing adjacent to the surgeon. If this occurs, the assistant's gown is considered contaminated and must be discarded.
Next, after the neck area is secured, the gown is draped on the surgeon, the rear strings tied and knotted, the surgeon breaks a “transfer card” into two portions. The transfer card releasably holds two free ends of a pair of waist strings that have fixed ends attached to the gown. After breaking the transfer card, one portion of the transfer card is given to the scrub nurse and the other portion is retained by the surgeon. Thereafter, the surgeon rotates 360 degrees while holding his portion of the transfer card that has one free end of its waist string attached thereto. As the surgeon rotates, the scrub nurse holds her portion of the transfer card that has the other free end of its waist string attached to the transfer card.
After the surgeon makes the complete 360 degree rotation, the surgeon retrieves the portion of the transfer card being held by the scrub nurse. The surgeon retrieves this portion of the transfer card from the scrub nurse without touching the scrub nurse in order to maintain sterility of the surgical gown. The surgeon touches only the transfer card as the surgeon retrieves the transfer card from the scrub nurse. At that point, the surgeon is in possession of both portions of the transfer card.
Next, the surgeon releases both free ends of the waist strings from their respective portions of the transfer card. The two portions of the transfer card are then discarded by being dropped to the floor. Next, the surgeon ties both free ends of the waist strings together about his waist.
The donning procedure is complete after the surgeon ties the two free ends of the waist strings together about his waist. In any event, surgical gowns are either of two basic types. In this regard, surgical gowns can be disposable (i.e., single-use) gowns made of non-woven material, such as a spread tow plastic film composite. Surgical gowns can also be reusable gowns made of woven cotton or woven synthetic material. Regardless of gown design, surgical gown designs marketed in interstate commerce are submitted to and cleared by the U.S. Food and Drug Administration as “501(k) premarket submissions” under 21 Code of Federal Regulations, Part 807.
Various means are used for manufacturing conventional disposable and reusable surgical gowns. Disposable surgical gowns can be made of non-woven material, such as a spread tow plastic film composite, as mentioned hereinabove. Reusable surgical gowns can be made of woven cotton or woven synthetic material, such as fine endless polyester fibers or various combinations of materials. Also, reusable surgical gowns may be laminated with layers of plastic film in combination with the cotton or synthetic material in order to prevent strike-through of liquids. In either case of disposable or reusable surgical gowns, the surgical gown material is selected so that the surgical gown is resistant to abrasion and tearing and so that the surgical gown releases practically no particulates.
Surgical gowns having dimensions for a particular size and style are cut from bales of the materials mentioned hereinabove. Seams are typically either sewn or ultrasonically bonded. The surgical gown is also sterilized to kill microorganisms before the surgical gown is properly folded, vacuum packaged and shipped to a medical facility, such as a hospital. Sterilization techniques include heat applied in an autoclave using either dry or wet heat. Alternatively, the sterilization technique may use ethylene oxide gas. Radiation also may be used as a sterilizing technique during the manufacturing process.
However, use of conventional surgical gowns obtains several disadvantages. In this regard, and as mentioned hereinabove, one disadvantage is some conventional surgical gown designs require two people to assist the surgeon in donning the surgical gown. The two persons are the circulating nurse and the scrub nurse. Inclusion of the circulating nurse in the donning procedure reduces the amount of time the circulating nurse has available to attend to her other duties, such as coordinating, planning and implementing nurse-related duties associated with the surgical procedure. Reducing the amount of time the circulating nurse has available to attend to her other duties decreases productivity and efficiency of the circulating nurse and therefore increases operating costs for the medical facility employing the circulating nurse.
Another disadvantage of some conventional gown designs is some conventional surgical gown designs do not provide for 360 degree sterility. With respect to conventional surgical gowns, the gap mentioned hereinabove may exist between the two longitudinally opposing edges of the open back portion of the gown. As previously mentioned, this gap may exist even after the circulating nurse ties and knots the plurality of strings distributed along the two longitudinally opposing edges of the open back portion of the gown. The gap necessarily increases the risk of exposing the non-sterile inside of the gown to the sterile surgical field. Therefore, some conventional gown designs have less than 360 degree sterility due to presence of the gap. This disadvantage associated with using some conventional gown designs having a gap in the rear thereof may limit mobility of the surgeon during the surgical procedure and may increase risk of contaminating gowns being worn by nearby surgical personnel, as mentioned hereinabove.
Yet another disadvantage associated with use of some conventional surgical gown designs is that the donning procedure is time consuming. For example, the circulating nurse must tie and knot a plurality of relatively small strings distributed along the two longitudinally opposing edges of the open back portion of the gown. The time used to tie and knot these strings increases the time to complete the surgical procedure and may increase the amount of time the patient is under anesthesia, which is undesirable.
Various approaches have been attempted to address the disadvantages mentioned hereinabove. For example, U.S. Pat. No. 4,214,320 titled “Surgical Gown and Method of Donning Gown” and issued Jul. 29, 1980 in the name of Nathan L. Belkin discloses a surgical gown that includes three arm holes, two of which have long covered sleeves. The third arm hole is a large opening in an extended side panel having a shoulder band along one edge to permit the length of the upper arm between the shoulder and elbow to pass through the large opening. A pull tab or donning tab is secured to the band, and is intended to be manipulated by an assistant during the donning of the gown. In the closed position, the extended panel completely covers the back and overlaps the other side and a front portion of the gown, with the band secured around the shoulder and sleeve. According to this patent, the sterile surgical gown is donned by completely wrapping it around the wearer to provide a secure enclosure which requires no fasteners or ties. An assistant holds the donning tab to guide the extended side panel and band off the sleeved arm extending through the third arm hole; then around the back of the wearer and over the sleeved arm. However, it would appear there is a risk that the surgical gown might inadvertently open due to movement of the surgeon during the surgical procedure because the gown does not use fasteners or ties.
Another approach is disclosed in U.S. Pat. No. 4,982,448 titled “Surgical Gown with Transfer Card” and issued Jan. 8, 1991 in the name of Walter Kogut. This patent discloses that, in a surgical gown belted by tie-strings, one of the tie-strings has one end secured to the gown and the other end releasably attached to a transfer card. Means is provided for adhesively, but releasably, securing the transfer card to the front of the gown. The second tie-string has one end secured to the gown and is temporarily tucked into and supported by a loop sewn or otherwise attached on the front of the gown. After the gown has been donned and the tie-strings have been tied together, the transfer card is thrown away. However, this patent does not appear to require both tie-strings to be releasably attached to the transfer card. Rather, the second tie-string is merely tucked into and supported by the loop sewn or otherwise attached on the front of the gown. Therefore, it would appear that the second tie-string may become inadvertently dislodged from the loop by movement of the surgeon or surgeon's assistant during gowning. Inadvertently dislodging the second tie-string from the loop may increase the risk that at least a portion of the second tie-string will freely and uncontrollably hang from the gown and become contaminated.
Yet another approach is disclosed in U.S. Pat. No. 7,549,179 B1 titled “Self-Donning Surgical Gown” and issued Jun. 23, 2009 in the name of Amgad Samuel Saied. This patent discloses a self-donning surgical gown comprising a plurality of pockets positioned strategically along the shoulders and back to allow the user to insert his hands into the shoulder and waist pockets to secure the surgical gown to his shoulders and back, respectively, without exposing his hands and arms to the non-sterile environment outside the traditional sterile field, thereby effectively increasing the sterile field and allowing the user to self-don the surgical gown. The pockets and/or the back flaps of the surgical gown may comprise fasteners, such as adhesives, hook-and-loop fasteners, ties, magnets, buttons or the like to fasten the self-donning surgical gown to itself or to a garment normally worn by the user. However, this patent appears to require a complicated procedure or extensive series of steps for placement of the wearer's hands into the plurality of pockets on the gown. Also, it appears that the procedure for placement of the wearer's hands into the plurality of pockets must be in a prescribed and precise order, so that the gown can be properly donned. Such a complicated procedure might be problematic during the rush of an emergency surgical procedure unless the surgeon is thoroughly familiar with the series of steps, and precise order of steps, required to don the gown. It would appear that substantial and time consuming training and retraining for a surgeon is required beforehand, so that the surgeon can properly and effortlessly use the gown during a surgical procedure. Time spent to perform such extensive training and retraining may increase operating costs for the medical facility.
An improved gown assembly technique, the use thereof providing improved barrier protection and material utilization, is disclosed in U.S. Pat. No. 6,115,839 titled “Surgical Gown and Method for Making the Same” and issued Sep. 12, 2000 in the names of David Loring Covington, et al. This patent discloses a surgical gown that includes opposed back panels having non-parallel side edges which define a slit. When the gown is in use, portions of the opposed back panels overlap along substantially the entire length of the slit. Ties are provided on the back panels for fastening the back panels together. Thus, the slit is covered and no gap in present between the opposed back panels. However, it would nonetheless appear that the gown is assembled to allow for back panels that are tied together. Tying of such back panels may be a time consuming process and inadvertent untying of the ties may expose portions of the non-sterile interior of the gown to the surrounding sterile surgical field. Exposure of the non-sterile interior of the gown to the surrounding sterile surgical field may result in contaminating the surgical field.
Although the prior art approaches recited hereinabove may disclose various surgical gown designs for use during a surgical procedure, the prior art recited hereinabove do not appear to disclose the surgical gown invention described and claimed hereinbelow.